YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 261 drug applications between 9 September 2022 and 15 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 35 drug names.
2022/09/09 – 2022/09/15
- New acceptances this week
- 261
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
261filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 44 |
| New drug | 28 |
| Import | 20 |
| Import re-registration | 8 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 189 |
| Therapeutic biologic | 39 |
| TCM | 31 |
| Prophylactic biologic | 2 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cefotiam Hydrochloride For Injection | 3 | 1 | 0 |
| 2 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 3 | Peramivir Injection | 2 | 1 | 7 |
| 4 | Vardenafil Hydrochloride Tablets | 2 | 1 | 4 |
| 5 | Minoxidil Liniment | 2 | 1 | 52 |
| 6 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 7 | Potassium Aspartate Injection | 2 | 1 | 3 |
| 8 | Aripiprazole Oral Solution | 2 | 1 | 4 |
| 9 | Morinidazole and Sodium Chloride Injection | 1 | 1 | 9 |
| 10 | 地氯雷他定口服溶液 · No verified English name | 1 | 1 | 26 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
152 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Jin Xing Industrial Co., Ltd. romanized | 10 | 6 | 0 |
| 2 | Shandong Kong Sheng Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Baxalta US Inc. | 6 | 1 | 0 |
| 4 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 8 | Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 4 | 4 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/15Import · Class 2.2 | 奥妥珠单抗注射液 · No verified English nameJXSL2200165 | F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/09/15Import · Class 1 | LY3819469注射液 · No verified English nameJXHL2200285 | Eli Lilly and Company |
| 2022/09/15Generic · Class 3 | Terbutaline Sulfate InjectionCYHS2201528 | Jilin Si Zhang Pharmaceutical Co., Ltd. romanized |
| 2022/09/15Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2201526 | Shanghai Ling Tong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2022/09/15Generic · Class 3 | Potassium Aspartate InjectionCYHS2201524 | Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized |
| 2022/09/15Generic · Class 3 | Potassium Aspartate InjectionCYHS2201521 | Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized |
| 2022/09/15Generic · Class 3 | Famotidine InjectionCYHS2201520 | Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2022/09/15Generic · Class 3 | Clonazepam InjectionCYHL2200077 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2022/09/15New drug · Class 2.3 | 芪参益气滴丸 · No verified English nameCXZL2200042 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2022/09/15New drug · Class 1 | 注射用MBS303 · No verified English nameCXSL2200461 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2022/09/15New drug · Class 1 | GR1802注射液 · No verified English nameCXSL2200460 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/15New drug · Class 1 | APG-115胶囊 · No verified English nameCXHL2200677 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2022/09/15New drug · Class 1 | APG-115胶囊 · No verified English nameCXHL2200676 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2022/09/15New drug · Class 1 | SC0062胶囊 · No verified English nameCXHL2200675 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2022/09/15New drug · Class 1 | SC0062胶囊 · No verified English nameCXHL2200674 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2022/09/15New drug · Class 2.4 | Regadenoson InjectionCXHL2200673 | Nanjing Rui Ke Wei Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/14Import · Class 1 | VAY736注射液 · No verified English nameJXSL2200164 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/09/14Generic · Class 3 | Magnesium Sulfate InjectionCYHS2201519 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/09/14Generic · Class 3 | Milnacipran Hydrochloride TabletsCYHS2201514 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2022/09/14Generic · Class 3 | Minoxidil LinimentCYHS2201512 | Ningbo Mei Shu Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/09/14Generic · Class 3 | Minoxidil LinimentCYHS2201511 | Ningbo Mei Shu Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/09/14New drug · Class 2.2 | 人干扰素α2b喷雾剂 · No verified English nameCXSL2200459 | Beijing Kai Yin Technology Co., Ltd. romanized |
| 2022/09/14New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSL2200458 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized |
| 2022/09/14New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2200457 | Zhejiang Quan Sheng Bio Technology Co., Ltd. romanized |
| 2022/09/13Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2201510 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2022/09/13Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201509 | Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2022/09/13Generic · Class 3 | Hydrotalcite SuspensionCYHS2201508 | Hangzhou Min Sheng Health Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/09/13New drug · Class 1 | SYH2045片 · No verified English nameCXHL2200672 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/13New drug · Class 1 | SYH2045片 · No verified English nameCXHL2200671 | Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/10Import · Class 1 | 利特昔替尼胶囊 · No verified English nameJXHS2200081 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd. |
38 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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